Wound Healing DisorderNCT06420323
NovoX®Cup as Primary Dressing After Breast Reduction
An observational study of Wound Healing Disorder and Post-Surgical Complication, run by MOSS S.p.A. at 1 site in Austria.
Trial summary
Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of life.However, as in every surgery, there can be complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wound Healing Disorder, Post-Surgical Complication, Mammaplasty
- What is being tested?
- Treatment with NovoX® Cup and Treatment with Omnistrip®
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 25 Jul 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients undergoing elective bilateral breast reduction surgery.
Who may be able to join
- Written informed consent
- Female patients 18 years and older
- Patient able to give informed consent
- Patients undergoing bilateral breast reduction
Who cannot join
- Absent informed consent
- Patients from protected groups and those who are not personally able to give consent.
- Patients younger than 18 years
- Pregnancy (pregnancy test before enrollment) and breastfeeding women
- Former radiation of the breast(s)
- Former surgery at the operation site
Show all 12Show fewer
- Skin abnormalities in the operation area (e.g. burn scars)
- Participation in other clinical trials during this study
- Active malignant disease
- Breast cancer history
- Radiation or chemotherapy during the study period or up to 6 months before possible enrollment
- Immune disease
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz
Graz, A-8036
About this study
Official title: NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup
Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of life.However, as in every surgery, there can be complications. Wound disorders, such as open wounds and skin loss account for the most commonly encountered postoperative complications. NovoX® Cup is a new single-use wound dressing that is shaped cupular in order to tightly adapt to the breast anatomy. It is internally coated with oxygen-enriched oil releasing reactive oxygen species and is free from active pharmaceutical ingredients. It is intended, among other indications, for the use in surgical wounds after oncological breast surgery, breast reconstruction and cosmetic breast surgery. In two studies, a total of 140 patients (surgical wounds after breast augmentation-mastopexy, mammary lesions) were treated successfully with NovoX® Cup and no product-related adverse events were reported.The claimed advantages sound promising but an advantage compared to established wound dressings such as sterile strips or tapes has still to be investigated.
The aim of the following study is to compare the outcomes (postoperative complications, scar quality and patients' satisfaction) of breast reduction and application of the wound dressing NovoX® Cup in comparison to already established wound closure systems 2 weeks and 3 months after surgery.
Read the detailed description
A prospective intra-individually controlled cohort study.
One breast will be chosen (left or right) to be treated with the NovoX®-Cup.
The other breast will serve as the "standard of care" control.
Randomization within this clinical investigation will be done intra-individually in a 1:1 ratio.
- Being tested
- Treatment with NovoX® Cup, Treatment with Omnistrip®
- Keywords
- Surgical wounds, Breast surgery, Plastic surgery, Oxygen-enriched oil, Dressing, Wound healing, Scar quality, postoperative complications, Breast reduction
- Medical subject headings
- Surgical Wound, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with NovoX® CupDevice
NovoX® Cup treatment
Treatment with Omnistrip®Device
Omnistrip® treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment with NovoX® Cup | Patient gets treated with NovoX® Cup for 2 weeks. Receives: Device: Treatment with NovoX® Cup | |
| Treatment with Omnistrip® | Patient gets treated with Omnistrip® for 2 weeks. Receives: Device: Treatment with Omnistrip® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar quality (Vancouver Scar Scale, VSS)
scar quality measured through VSS scale (total scores 0 to 13), higher scores indicate worse scar outcome
Measured: 2 weeks and 3 months after surgery.
Scar quality (Patient and Observer Scar Assessment Scale, POSAS)
scar quality measured through POSAS scale (total scores 6 to 60), higher scores indicate worse scar outcome
Measured: 2 weeks and 3 months after surgery.
Wound healing disorder
occurrence of wound healing disorders (yes/no)
Measured: 2-weeks and 3 months post-surgery
Secondary outcomes (5)
Pain (Numerical Scale Rating NRS)
Pain evaluated with Numerical Scale Rating (NRS score 0 to 10) higher score indicates worse pain
Measured: before surgery, 2-weeks and 3 months post-surgery
Surgical Complications (Clavien-Dindo-Classification CDC)
Clavien-Dindo-Classification (CDC grade I to V) of surgical complications, higher grade indicates higher severity of the complications
Measured: 3 months post-surgery
Breast-Q® Outcome
Breast-Q® questionnaire satisfaction with outcome (scores 0 - 100 for each breast), higher score indicates greater satisfaction
Measured: before surgery, 2 weeks and 3 months post-surgery
Breast-Q® breasts
Breast-Q® questionnaire satisfaction with breasts (scores 0 - 100 for each breast), higher score indicates greater satisfaction
Measured: before surgery, 2 weeks and 3 months post-surgery
Breast-Q® nipples
Breast-Q® questionnaire satisfaction with nipples (scores 0 - 100 for each breast), higher score indicates greater satisfaction
Measured: before surgery, 2 weeks and 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start25 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MOSS S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars-Peter Kamolz, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420323
- Sponsor's protocol ID
- NOVOX CUP
- Status last verified
- Oct 2026
- First submitted
- 14 May 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup
- ClinicalTrials.gov ID
- NCT06420323
- Acronym / sponsor ID
- NOVOX CUP
- Keywords
- Surgical wounds, Breast surgery, Plastic surgery, Oxygen-enriched oil, Dressing, Wound healing, Scar quality, postoperative complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MOSS S.p.A.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of life.However, as in every surgery, there can be complications. Wound disorders, such as open wounds and skin loss account for the most commonly encountered postoperative complications. NovoX® Cup is a new single-use wound dressing that is shaped cupular in order to tightly adapt to the breast anatomy. It is internally coated with oxygen-enriched oil releasing reactive oxygen species and is free from active pharmaceutical ingredients. It is intended, among other indications, for the use in surgical wounds after oncological breast surgery, breast reconstruction and cosmetic breast surgery. In two studies, a total of 140 patients (surgical wounds after breast augmentation-mastopexy, mammary lesions) were treated successfully with NovoX® Cup and no product-related adverse events were reported.The claimed advantages sound promising but an advantage compared to established wound dressings such as sterile strips or tapes has still to be investigated.
The aim of the following study is to compare the outcomes (postoperative complications, scar quality and patients' satisfaction) of breast reduction and application of the wound dressing NovoX® Cup in comparison to already established wound closure systems 2 weeks and 3 months after surgery.
Detailed description
A prospective intra-individually controlled cohort study.
One breast will be chosen (left or right) to be treated with the NovoX®-Cup.
The other breast will serve as the "standard of care" control.
Randomization within this clinical investigation will be done intra-individually in a 1:1 ratio.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with NovoX® Cup | – | Device: Treatment with NovoX® CupPatient gets treated with NovoX® Cup for 2 weeks. |
| Treatment with Omnistrip® | – | Device: Treatment with Omnistrip®Patient gets treated with Omnistrip® for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients undergoing elective bilateral breast reduction surgery.
Key inclusion criteria (4 listed)
- Written informed consent
- Female patients 18 years and older
- Patient able to give informed consent
- Patients undergoing bilateral breast reduction
Key exclusion criteria (12 listed)
- Absent informed consent
- Patients from protected groups and those who are not personally able to give consent.
- Patients younger than 18 years
- Pregnancy (pregnancy test before enrollment) and breastfeeding women
- Former radiation of the breast(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with NovoX® CupNovoX® Cup treatment | Device | Treatment with NovoX® Cup |
| Treatment with Omnistrip®Omnistrip® treatment | Device | Treatment with Omnistrip® |
Primary outcome
Scar quality (Vancouver Scar Scale, VSS)
Time frame: 2 weeks and 3 months after surgery.
scar quality measured through VSS scale (total scores 0 to 13), higher scores indicate worse scar outcome
Scar quality (Patient and Observer Scar Assessment Scale, POSAS)
Time frame: 2 weeks and 3 months after surgery.
scar quality measured through POSAS scale (total scores 6 to 60), higher scores indicate worse scar outcome
Wound healing disorder
Time frame: 2-weeks and 3 months post-surgery
occurrence of wound healing disorders (yes/no)
5 secondary outcomes
Pain (Numerical Scale Rating NRS)
Time frame: before surgery, 2-weeks and 3 months post-surgery
Surgical Complications (Clavien-Dindo-Classification CDC)
Time frame: 3 months post-surgery
Breast-Q® Outcome
Time frame: before surgery, 2 weeks and 3 months post-surgery
Breast-Q® breasts
Time frame: before surgery, 2 weeks and 3 months post-surgery
Breast-Q® nipples
Time frame: before surgery, 2 weeks and 3 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars-Peter Kamolz, Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing Disorder and Post-Surgical Complication, run by MOSS S.p.A. at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar quality (Vancouver Scar Scale, VSS) (time frame: 2 weeks and 3 months after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.